---
title: "List the medicine facts before any access request is written"
url: "https://ailawframework.com/practice/health-and-medical-law/prepare-a-special-access-scheme-application-or-notification-for-an-unapp/united-states"
type: "task_jurisdiction_version"
site: "AI Law Framework"
id: "A32-R20261018-6-US"
practice_area: "Health & Medical Law"
tier: "red"
lawyer_review: "required"
jurisdictions: ["US"]
last_reviewed: "2026-10-22"
---

# List the medicine facts before any access request is written

> List the medicine name, the strength if the file states it, and the condition in the file's words. Do not name a form and do not write an application.

Canonical page: https://ailawframework.com/practice/health-and-medical-law/prepare-a-special-access-scheme-application-or-notification-for-an-unapp/united-states  
Last reviewed: 2026-10-22

Site index for agents: https://ailawframework.com/llms.txt

## Key facts

| Fact | Value |
| --- | --- |
| Practice area | [Health & Medical Law](https://ailawframework.com/practice/health-and-medical-law.md) |
| Human involvement | Red: Lawyer writes; AI may check, clarify or collect data |
| How AI is used | List the medicine name, the strength if the file states it, and the condition in the file's words. Do not name a form and do not write an application. |
| What the lawyer must review | You write any request for an unapproved medicine. No special-access or unapproved-drug rule was opened, so you do not name a pathway or a form number. 45 CFR § 164.502(a) limits use and disclosure of the patient's information. Model Rule 1.6(a) limits revelation of information relating to the representation. Model Rule 1.6(c) requires reasonable efforts against inadvertent disclosure. Formal Opinion 512 requires informed consent before that information goes into a self-learning tool whose output could disclose it. The patient's name stays in the file unless you decide a disclosure is permitted. |
| Written for | United States |
| Applies to | [Prepare a Special Access Scheme application or notification for an unapproved medicine](https://ailawframework.com/practice/health-and-medical-law/prepare-a-special-access-scheme-application-or-notification-for-an-unapp.md) |

## Checking plan

- What the AI does: List the medicine name, the strength if the file states it, and the condition in the file's words. Do not name a form and do not write an application.
- Basis: Checked against the linked sources on 22 October 2026. Confirm the current instrument before reliance.

## Notes

- Do not describe a dosing regimen. You write any clinical statement, with the prescriber.
- An application for an unapproved medicine is a document you sign or the prescriber signs.

## Sources

- [45 CFR § 164.502 (uses and disclosures of protected health information)](https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-E/section-164.502) (checked 2026-10-22)
- [ABA Model Rule 1.6, Confidentiality of Information](https://www.americanbar.org/groups/professional_responsibility/publications/model_rules_of_professional_conduct/rule_1_6_confidentiality_of_information/) (checked 2026-10-22)
- [ABA Formal Opinion 512, Generative Artificial Intelligence Tools (29 July 2024)](https://www.americanbar.org/content/dam/aba/administrative/professional_responsibility/ethics-opinions/aba-formal-opinion-512.pdf) (checked 2026-10-22)

*Practice guidance for planning and review. Confirm current primary sources and the requirements of the actual matter. This is general information, not legal advice.*